FDA recall D-0645-2021

DIBAR NUTRICIONAL S DE RL DE CV · Class II · drug

Product

DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090 00302 0 and b) 8 FL OZ (236.5 mL) bottle, NDC 73009-0001-08, UPC 8 53090 00301 3; Distributed by: S.E.N.D, LLC., Anthony, NM 88021; Imported by: Dibar Labs, LLC., Sugar Land, TX 77479, Made in Mexico.

Reason for recall

CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2021-05-11
Report date: 2021-07-07
Termination date: 2023-03-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Morelia, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0645-2021